EluRyng is a birth control medication used to prevent pregnancy. It is a single product containing 2 kinds of female hormones: etonogestrel, a progestin, and ethinyl estradiol, an estrogen. EluRyng works by preventing ovulation (the release of an egg from the ovaries). It also changes the lining of the uterus (womb) to prevent pregnancy from developing and changes the mucus at the cervix (opening of the uterus) to prevent sperm from entering.

This medication comes as a flexible vaginal ring and is inserted and left in place for 3 weeks. After 3 weeks, it is removed for a 1-week break, then a new ring is inserted.

Common side effects include tissue irritation, headache, mood changes, and weight gain.

EluRyng is a prescription birth control medication used to prevent pregnancy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with EluRyng. See the "EluRyng Precautions" section.

Common side effects include:

• tissue irritation inside your vagina or on your cervix 
• headache (including migraine) 
• mood changes (including depression, especially if you had depression in the past). Call your healthcare provider immediately if you have any thoughts of harming yourself. 
• EluRyng problems, including the ring slipping out or causing discomfort 
• nausea and vomiting 
• vaginal discharge 
• weight gain 
• vaginal discomfort 
• breast pain, discomfort, or tenderness 
• painful menstrual periods 
• abdominal pain 
• acne 
• less sexual desire 

Some women have spotting or light bleeding during EluRyng use. If these symptoms occur, do not stop using EluRyng. The problem will usually go away. If it doesn’t go away, check with your healthcare provider. 

Other side effects seen with EluRyng include breast discharge; vaginal injury (including pain, discomfort, and bleeding) associated with broken rings; and penis discomfort of the partner (such as irritation, rash, itching). 

Less common side effects seen with combination hormonal birth control include: 

• Blotchy darkening of your skin, especially on your face 
• High blood sugar, especially in women who already have diabetes 
• High fat (cholesterol, triglycerides) levels in the blood 

There have been reports of the ring becoming stuck to the vaginal tissue and having to be removed by a healthcare provider. Call your healthcare provider if you are unable to remove your EluRyng.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of EluRyng. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all medicines and herbal products you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. 

Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to: 

• certain anti-seizure medicines (such as barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide and topiramate) 
• medicine to treat fungal infections (griseofulvin) 
• certain combinations of HIV medicines, (such as nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir) 
• certain hepatitis C (HCV) medicines (such as boceprevir and telaprevir) 
• non-nucleoside reverse transcriptase inhibitors (such as efavirenz and nevirapine) 
• medicine to treat tuberculosis (such as rifampicin and rifabutin) 
• medicine to treat high blood pressure in the vessels of the lung (bosentan) 
• medicine to treat chemotherapy-induced nausea and vomiting (aprepitant) 
• St John’s wort 

Use an additional barrier contraceptive method (such as a male condom with spermicide) when you take medicines that may make EluRyng less effective. Since the effect of another medicine on EluRyng may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long to help prevent you from becoming pregnant. While using EluRyng, you should not use certain female barrier contraceptive methods such as a vaginal diaphragm, cervical cap or female condom as your back-up method of birth control because EluRyng may interfere with the correct placement and position of a diaphragm, cervical cap or female condom.

Some medicines and grapefruit juice may increase the level of ethinyl estradiol in your blood if used together, including: 

• the pain reliever acetaminophen 
• ascorbic acid (vitamin C) 
• medicines that affect how your liver breaks down other medicines (such as itraconazole, ketoconazole, voriconazole, fluconazole, clarithromycin, erythromycin, and diltiazem) 
• certain HIV medicines (atazanavir/ritonavir and indinavir) 
• non-nucleoside reverse transcriptase inhibitors (such as etravirine) 
• medicines to lower cholesterol such as atorvastatin and rosuvastatin 

Hormonal birth control methods may interact with lamotrigine, a medicine used for seizures. This may increase the risk of seizures, so your healthcare provider may need to adjust your dose of lamotrigine. 

Women on thyroid replacement therapy may need increased doses of thyroid hormone. 

Ask your healthcare provider if you are not sure if you take any of the medicines listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Serious side effects have been reported with EluRyng including the following:

• Blood clots. Like pregnancy, combination hormonal birth control methods increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start using a combination hormonal birth control method or when you restart the same or different combination hormonal birth control method after not using it for a month or more. Talk with your healthcare provider about your risk of getting a blood clot before using EluRyng or before deciding which type of birth control is right for you. It is possible to die or be permanently disabled from a problem caused by a blood clot, such as heart attack or stroke. Some examples of serious blood clots are blood clots in the:
  • legs (deep vein thrombosis)
  • lungs (pulmonary embolism)
  • eyes (loss of eyesight)
  • heart (heart attack)
  • brain (stroke)
• Call your healthcare provider right away if you have:
  • leg pain that does not go away
  • sudden shortness of breath
  • sudden blindness, partial or complete
  • severe pain or pressure in your chest
  • sudden, severe headache unlike your usual headaches
  • weakness or numbness in an arm or leg, or trouble speaking
  • yellowing of the skin or eyeballs

Other serious risks include:

• Toxic Shock Syndrome (TSS). Some of the symptoms are much the same as the flu, but they can become serious very quickly. Call your healthcare provider or get emergency treatment right away if you have the following symptoms:
  • sudden high fever
  • vomiting
  • diarrhea
  • a sunburn-like rash
  • muscle aches
  • dizziness
  • fainting or feeling faint when standing up
• liver problems, including liver tumors
• high blood pressure
• gallbladder problems
• accidental insertion into bladder
• symptoms of a problem called angioedema if you already have a family history of angioedema

Do not use EluRyng if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination hormonal contraceptives (CHCs), including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Do not use EluRyng if you: 

• smoke and are over 35 years old 
• have or have had blood clots in your arms, legs, eyes, or lungs 
• have an inherited problem with your blood that makes it clot more than normal 
• have had a stroke 
• have had a heart attack 
• have certain heart valve problems or heart rhythm problems that can cause blood clots to form in the heart 
• have high blood pressure that medicine can't control 
• have diabetes with kidney, eye, nerve, or blood vessel damage 
• have certain kinds of severe migraine headaches with aura, numbness, weakness, or changes in vision, or have any migraine headaches if you are over age 35 
• have liver disease, including liver tumors 
• take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood 
• have unexplained vaginal bleeding 
• are pregnant or think you may be pregnant. EluRyng is not for pregnant women. 
• have or have had breast cancer or any cancer that is sensitive to female hormones 
• are allergic to etonogestrel, ethinyl estradiol or any of the ingredients in EluRyng.

Hormonal birth control methods may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy or related to previous use of hormonal birth control. 

Tell your healthcare provider if you have ever had any of the conditions listed above. Your healthcare provider can suggest another method of birth control.

Grapefruit and grapefruit juice may interact with EluRyng and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you use EluRyng tell your healthcare provider if you:

• have any medical conditions 
• smoke 
• are pregnant or think you are pregnant 
• recently had a baby 
• recently had a miscarriage or abortion 
• have a family history of breast cancer 
• have or have had breast nodules, fibrocystic disease, an abnormal breast x-ray, or abnormal mammogram 
• use tampons and have a history of toxic shock syndrome 
• have been diagnosed with depression 
• have had liver problems including jaundice during pregnancy 
• have or have had elevated cholesterol or triglycerides 
• have or have had gallbladder, liver, heart, or kidney disease 
• have diabetes 
• have a history of jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy) 
• have a history of scanty or irregular menstrual periods 
• have any condition that makes the vagina become irritated easily 
• have or have had high blood pressure 
• have or have had migraines or other headaches or seizures 
• are scheduled for surgery. EluRyng may increase your risk of blood clots after surgery. You should stop using EluRyng at least 4 weeks before you have surgery and not restart it until at least 2 weeks after your surgery. 
• are scheduled for any laboratory tests. Certain blood tests may be affected by hormonal birth control methods. 
• are breastfeeding or plan to breastfeed. Hormonal birth control methods that contain estrogen, like EluRyng, may decrease the amount of milk you make. A small amount of hormones from EluRyng may pass into your breast milk. Consider another non-hormonal method of birth control until you are ready to stop breastfeeding.
• have (or have ever had) an allergic reaction while using EluRyng, including hives, swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (anaphylaxis and/or angioedema).

Tell your healthcare provider about all medicines and herbal products you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

EluRyng should not be used during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. Research studies have not shown an increased risk of birth defects when the mother has taken low dose similar methods of birth control prior to conception or during early pregnancy. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

The effects of EluRyng in nursing mothers have not been established and are unknown. When possible, the nursing mother should be advised to use other forms of contraception until she has completely weaned her child. Combination hormonal contraceptives can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however it can occur at any time in some women. Small amounts of contraceptive steroids and/or metabolites are present in breast milk.

Use EluRyng exactly as prescribed. 

• EluRyng is used in a 4-week cycle. 
  • Insert 1 EluRyng in the vagina and keep it in place for 3 weeks (21 days). 

    Regularly check that EluRyng is in your vagina (for example, before and after intercourse) to ensure that you are protected from pregnancy.

  • Remove the EluRyng for a 1-week break (7 days). During the 1-week break (7 days), you will usually have your menstrual period. 

    Note: Insert and remove EluRyng on the same day of the week and at the same time: 

    • For example, if you insert your EluRyng on a Monday at 8:00 am, you should remove it on the Monday 3 weeks later at 8:00 am. 
    • After your 1-week (7 days) break, you should insert a new EluRyng on the next Monday at 8:00 am. 
• While using EluRyng, you should not use certain female barrier contraceptive methods such as a vaginal diaphragm, cervical cap or female condom as your back-up method of birth control because EluRyng may interfere with the correct placement and position of a diaphragm, cervical cap or female condom. 
• Ring breakage has occurred when also using a vaginal product such as a lubricant or treatment for infection. Use of spermicides or vaginal yeast products will not make EluRyng less effective at preventing pregnancy. 
• Use of tampons will not make EluRyng less effective or stop EluRyng from working. 
• If EluRyng has been left inside your vagina for more than 4 weeks (28 days), you may not be protected from pregnancy and you should see your healthcare provider to be sure you are not pregnant. Until you know the results of your pregnancy test, you should use an extra method of birth control, such as male condoms with spermicide, until the new EluRyng has been in place for 7 days in a row. 
• Do not use more than 1 EluRyng at a time. Too much hormonal birth control medicine in your body may cause nausea, vomiting, or vaginal bleeding. 

Your healthcare provider should examine you at least 1 time a year to see if you have any signs of side effects from using EluRyng.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

EluRyng is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring. It contains 11.7mg of etonogestrel and 2.7mg of ethinyl estradiol. When placed in the vagina, each ring releases on average 0.120mg/day of etonogestrel and 0.015mg/day of ethinyl estradiol over a three-week period of use.

If you use too much EluRyng, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store EluRyng at room temperature between 68°F to 77°F (20°C to 25°C). 
• Store EluRyng at room temperature for up to 4 months after you receive it. Throw EluRyng away if the expiration date on the label has passed. 
• Do not store EluRyng above 86°F (30°C). 
• Avoid direct sunlight. 
• Place the used EluRyng in the re-closable foil pouch and properly throw it away in your household trash out of the reach of children and pets. Do not flush your used EluRyng down the toilet. 

Keep EluRyng and all medicines out of the reach of children.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including EluRyng, should not be used by women who are over 35 years of age and smoke.